Patients with multiple sclerosis (MS) can now get monthly Zinbryta injections as the U.S. Food and Drug Administration approved its use.
The FDA approved on May 27 the use of Zinbryta (daclizumab) for adults suffering from worsening forms of MS. Zinbryta is a self-administered long-acting monthly injection manufactured by Biogen, Inc.
Prior to the approval, the efficacy of Zinbryta was tested in two clinical trials. The first trial was a comparison between the effects of Avonex and Zinbryta in 1,841 study participants over the course of 144 weeks. It was noted that those on Zinbryta experienced fewer MS relapses than those on Avonex. In another trial involving 412 patients, Zinbryta was compared with placebo for 52 weeks and results showed that patients on Zinbryta experienced fewer relapses.
Biogen chief medical officer and executive vice president Alfred Sandrock said the FDA approval signifies the company's thrust toward offering therapies for MS patients.
"Zinbryta is the first once-monthly, self-administered treatment in MS, and it demonstrated superior efficacy over a widely used interferon," said Sandrock. "Clinical data showed Zinbryta significantly reduced relapses and brain lesions for up to three years compared to Avonex (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring."
"Zinbryta provides an additional choice to patients who may require a new option for treatment," said Dr. Billy Dunn, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Zinbryta Adverse Effects
While Zinbryta is proven to be effective, it has serious side effects. Patients on Zinbryta can suffer from liver injury with increase in alanine aminotransferase. Health care professionals must obtain blood tests before starting Zinbryta for baseline data then prior to the patient's monthly dose. Patients must also be followed-up six months after the final dose.
Zinbryta can also cause immune conditions such as non-infectious colitis, upper respiratory tract infection, lymphadenopathy, nasopharyngitis and skin reactions such as dermatitis, eczema and rashes. Depression and suicidal thoughts were also noted in patients who took Zinbryta.
Early this year, researchers have found strong evidence that MS patients with associated optic neuritis respond well with phenytoin, a common seizure drug.
